Covering for a medical scoping device

ABSTRACT

The present invention relates to a cover having a plurality of moveable, external, angled projecting elements for use with flexible medical scoping devices such as endoscopesor enteroscopes. The invention includes the cover with an over cuff and use of the disposable removable covering in methods of medical scoping procedures or examinations. The invention also includes an applicator for assisting in placing the covering about or over a medical device and a kit of parts.

RELATED APPLICATIONS

This application is a 35 U.S.C. §371 national stage application of PCTApplication No. PCT/GB2011/050981, filed on May 24, 2011, which claimspriority from British Application No. 1107535.5, filed on May 6, 2011,British Application No. 1101619.3, filed on Jan. 31, 2011, and BritishApplication No. 1008637.9 filed on May 25, 2010. The contents of each ofthese applications are incorporated herein by reference in theirentireties. The above-referenced PCT International Application waspublished as International Publication No. WO 2011/148172 A2 on Dec. 1,2011.

The present invention relates to a covering or sheath or sleeve or cuffhaving external projections for use with a medical device and inparticular for use with flexible medical scoping devices such asendoscopes or enteroscopes. The invention includes inter alia use of thedisposable removable covering in methods of medical scoping proceduresor examinations, particularly but not exclusively, where the site is thecolon or small intestine. The invention also includes a kit including anapplicator for assisting in placing the covering about or over a medicalscoping device.

BACKGROUND

In endoscopic examinations/procedures, flexible instruments designed toview the gastro-intestinal tract are inserted along a body cavity to aninternal part such as the stomach, duodenum, small intestine or largeintestine. The instruments are provided with fibre-optic orcharge-couple device (CCD) cameras which enable images to be transmittedaround bends and images to be produced to displays on a televisionscreen. Accordingly, it is possible to view the inside surfaces of theoesophagus, stomach and duodenum using a gastroscope, the smallintestine with an enteroscope, part of the colon using a flexiblesigmoidoscope and the whole of the large intestine (the bowel) with acolonoscope.

Enteroscopy is the endoscopic examination of the small intestine whereascolonoscopy is the endoscopic examination of the colon and the distalpart of the small bowel and flexible sigmoidoscopy is the examination ofthe rectum and lower part of the bowel. Each scoping procedure mayprovide a visual diagnosis (e.g. ulceration, polyps) and grants theopportunity for biopsy or removal of suspected lesions. Whilstcolonoscopic and enteroscopic examinations are the most effectivetechniques to assess the state of health of the bowel, they areinconvenient, uncomfortable, expensive procedures that are associatedwith significant risks of potentially serious complications. The mostcommon complications are: failure to achieve a complete examination(5-10%); failure to detect a polyp (up to 20%); reaction to intravenousdrugs; over-sedation leading to hypoxia and cardio-vascular collapse;splenic injury (rare); bowel perforation, (1 in 500-1500); fullthickness burn (uncommon) and; bleeding following polypectomy.

A further disadvantage of colonoscopic and enteroscopic procedures isthat they are time consuming for patients and medical personnel alike,the procedure can take anywhere from 20 minutes to 2 hours depending onhow difficult it is to advance a scope through the colon or smallintestine. The colonoscopy itself takes around thirty minutes to performbut in some cases may require up to an hour, and for the patient, thereis a recovery period of up to two hours in hospital whilst sedationpasses off and over that time clinical observation is needed. Typically,the number of clinically competent personnel required to conduct acolonoscopic procedure are an endoscopist specialist and threeassistants including the person responsible for reprocessing theequipment. In addition, staffing is required for the recovery area.

Two yet further additional significant difficulties associated withcolonoscopy and scoping procedures more generally are as follows:

Firstly, the anatomy of the colon is such that the lining is thrown intofolds. As the tip of the endoscope passes along the lumen of the colon,these folds hamper the endoscopist's ability to visualise the entiresurface of the mucosa and in particular, detect pre-malignant andmalignant lesions tucked away on the proximal face of these folds duringextubation.

Secondly, the position of the tip of may be difficult to maintain fromthe moment at which a lesion or polyp is detected to the completion ofany therapeutic procedure. As the colonoscope is withdrawn the tip doesnot travel back at a constant speed but rather with jerks and slippagesparticularly when traversing a bend or length of colon where the bowelhas been concertinaed over the endoscope shaft during intubation. Thetip of the device may, at any moment, slip backwards thereby causing theclinician to lose position. If tip position is lost, the clinician isrequired to relocate the lesion or polyp for the therapeutic procedureto be continued.

The colonoscopic procedure is not simple because the bowel is long andconvoluted. In places it is tethered by peritoneal bands and in othersit lies relatively free. When the tip of the endoscope encounters atight bend the free part of the colon “loops” as more of the endoscopeis introduced and so looping occurs in the free part of the colon beforethe bend when there is difficulty negotiating the bend. This leads tostretching of the mesentery of the loop (the tissue that carries thenerves and blood vessels to the bowel). If the stretching is continuedor severe while the endoscopist pushes round the bend, the patientexperiences pain the blood pressure falls and the pulse slows. Loopformation is the main cause of failure or delay in completing anexamination. It is responsible for the pain experienced by the patientand the need for heavy sedation that in turn leads to cardio-respiratorycomplications. It is also the major cause of perforation in patients notundergoing a therapeutic procedure.

Attempts have been made to try to overcome the problems associated withcolonoscopic procedures, for example, it is known in the prior art toprovide endoscope sheaths having differential frictional resistanceprovided by very small external protrusions such as wedge-shapedprofiles or scales so there is low frictional resistance during forwardmovement of the covered endoscope shaft through a body cavity and agreater frictional resistance during its rearward movement. In practicehowever little improvement is achieved in overcoming looping. It is alsoknown from the prior art to use a double balloon enteroscope or anAer-O-Scope™. The double balloon enteroscope requires a substantialamount of additional kit, a high level of operator skill in timing thesequential inflation and deflation of the balloons and moreover it is alengthy procedure sometimes taking hours. The Aer-O-Scope™ provides lowpressure colon insufflations with CO₂ to propel the balloon along“slippery” colon walls without forceful maneuvering but cannot be usedfor biopsy or therapy.

Despite the forgoing drawbacks, for the foreseeable future colonoscopywill remain the procedure of choice for the examination of the largebowel. Newer methods for the detection of polyps and cancer usingnon-invasive technology may be identified but to obtain biopsies, removepolyps and to treat intra-colonic lesions no alternatives have appearedto date.

An improved medical scoping device that could reduce the time taken forthe colonoscopist or enteroscopist to perform the procedure would offerimmediate advantages to patients and clinicians alike.

An improved medical scoping device that could reduce the risk ofcomplications during a procedure would offer immediate advantages topatients and clinicians alike.

A medical scoping device that could improve endoscopic intubation,extubation and visualisation of the large bowel would offer immediateadvantages to both patients and clinicians alike.

A medical scoping device that could reduce loss of tip position during amedical procedure would offer immediate advantages to both patients andclinicians alike.

An improved medical scoping device that could reduce the requirement orlevel of sedation for a patient would offer immediate advantages to bothpatients and clinicians alike.

An improved medical scoping device that could overcome the problemsassociated with looping and so reduce discomfort to the person on whomthe procedure was being performed, would offer immediate advantages topatients and clinicians alike.

BRIEF SUMMARY OF THE DISCLOSURE

According to a first aspect of the present invention there is provided acover for a medical scoping device shaft, the cover comprising anelongate tubular member and being arranged for application over themedical scoping device shaft with the cover extending along at least apart of the length of a distal end of the shaft, the tubular membercomprising an inner surface at least a part of which grips the shaft andacts to hold the cover in place and an outer surface comprising aplurality of spaced projecting elements having a tip and a base that aremoveable between a resting position to a position wherein the tip of theprojecting element is substantially parallel to a longitudinal axis ofthe medical scoping device and to a position that is at an angle that isapproximately perpendicular to the longitudinal axis of the medicalscoping device shaft so that the said projecting elements are fanned outto contact with and provide support for and to dilate a lumen wall of abody passage into which the medical scoping device has been inserted.

According to a second aspect of the invention there is provided amedical scoping device comprising an air suction means for removing airfrom a body passage, an elongate flexible shaft having a proximal endassociated with a viewing means and a distal end, the medical scopingdevice further comprising the cover of the first aspect of the inventionreleasably attached thereto and covering at least a part of the shaft atits distal end.

According to a third aspect of the invention there is provided a coveraccording to a first aspect of the invention or a medical scoping deviceof the second aspect of the invention for use in a scoping procedure.

According to a fourth aspect of the invention there is provided anapplicator for attaching a cover to a shaft of a medical scoping device,the applicator comprising a pair of complimentarily mated casings eachsized and shaped so as to accommodate a cover for a medical scopingdevice therein, each casing further comprising an engaging means forreleasably engaging the casings to one another and each casingcomprising at least one securing means for securing a proximal end ofthe said cover thereto.

According to a fifth aspect of the invention there is provided a kitcomprising at least one cover according to the first aspect of theinvention and an applicator according to the fourth aspect of theinvention, optionally the kit further includes a medical scoping deviceand/or a cutting means and/or a distal end cap.

According to a sixth aspect of the invention there is provided a methodof avoiding looping in a medical scoping procedure, the methodcomprising inserting a medical scoping device shaft having an airsuction means for removing air from a body passage into an orifice of anindividual under investigation, the medical scoping device furthercomprising a cover releasably attached to the medical scoping deviceshaft and covering at least a part of the shaft at its distal end,wherein the cover comprises an elongate tubular member having an innersurface at least a part of which grips the shaft and acts to hold thecover in place and an outer surface comprising a plurality of spacedprojecting elements, and wherein when advancing the medical scopingdevice into the patient's bowel or small intestine and the distal endencounters a bend or loop in the patient's bowel or small intestine, themedical scoping device is withdrawn towards its proximal end causing theprojecting elements to splay or fan out and to dilate the lumen of thebowel or small intestine whilst holding the medical scoping device inposition, if necessary air is then drawn out causing the body passagewalls to collapse around and about the projecting elements therebydrawing the body passage wall into spaces between the projectingelements so said projecting elements engage with and grip the bodypassage wall, the medical scoping device is then further withdrawntowards the proximal end causing it to straighten and the body passagewall to concertina along the shaft of the scope proximal to the bend orloop whilst the lumen ahead of the distal end opens up, the medicalscoping device is then advanced towards its distal end and the bend orloop is navigated.

According to a seventh aspect of the invention there is provided amethod of improving endoscopic visualisation, the method essentiallycomprising the steps of the sixth aspect of the invention wherein theprojecting elements open a lumen and evert thereby flattening colonicfolds for inspection during withdrawal whereby visualisation is furtherenhanced as colonic folds revert to their normal anatomical positionpermitting light from the medical scoping device to play across themucosa, thus enabling careful visualisation of the surface of the mucosathat was hitherto hidden or difficult to view.

According to an eighth aspect of the invention there is provided amethod of maintaining tip position and improving tip control during anexamination, the method essentially comprising the steps of the sixthaspect of the invention wherein the projecting elements maintain themedical scoping device tip in a central part of the bowel lumen as thedevice moves in a proximal direction thereby holding the mucosa toprevent the tip from flipping backwards so as to maintain positionduring therapy.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention are further described hereinafter withreference to the accompanying drawings, in which:

FIG. 1 shows one embodiment of the cover according to the presentinvention.

FIG. 2 shows a transverse section through the cover of FIG. 1.

FIG. 3 shows in detail a longitudinal section of the distal end of thecover of FIG. 1.

FIG. 4 shows a disassembled applicator and cover.

FIG. 5 shows an assembled applicator and cover.

FIG. 6A shows a top view of an applicator, FIG. 6B shows a side view,FIG. 6C shows a top view of a disassembled applicator and cover, FIG. 6Dshows a proximal end view and FIG. 6E shows a distal end view.

FIG. 7 shows a side view of a viewing means attachment.

FIG. 8A-E shows different embodiments of the projecting elements.

FIG. 9A shows the cover of the present invention having one embodimentof the projecting elements closing means and FIG. 9B shows a coverhaving flattened projecting elements.

FIG. 10 shows an alternative embodiment of the cover of the invention;FIG. 10A shows a top plan view and FIG. 10B shows an underside planview.

FIG. 11 shows a series of different views of an alternative embodimentof the cover of present invention including an over cuff; FIG. 11A showsa transverse through section; FIG. 11B shows a front view and FIGS. 11Cand 11D show bottom and top side angled views; and FIG. 11E shows thecover including the over cuff placed over the distal end of a medicalscoping device.

FIG. 12 shows a series of schematic anatomical through sections of amedical scoping device with a cover of the present invention includingthe over cuff, in the course of a medical scoping procedure. FIG. 12Ashows insertion of the scoping device and cover via the anus into thecolon of an individual undergoing an endoscopic procedure; FIG. 12Bshows forward passage along the colon; FIG. 12C shows controlledwithdrawal, flattening of the colonic wall and improved visualisationand; FIG. 12D shows air suction causing the colon wall to collapse orwrap around the device and to grip the cover and device.

DETAILED DESCRIPTION

Throughout the description and claims of this specification, the words“comprise” and “contain” and variations of them mean “including but notlimited to”, and they are not intended to (and do not) exclude othermoieties, additives, components, integers or steps. Throughout thedescription and claims of this specification, the singular encompassesthe plural unless the context otherwise requires. In particular, wherethe indefinite article is used, the specification is to be understood ascontemplating plurality as well as singularity, unless the contextrequires otherwise.

Features, integers, characteristics, compounds, chemical moieties orgroups described in conjunction with a particular aspect, embodiment orexample of the invention are to be understood to be applicable to anyother aspect, embodiment or example described herein unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The invention is notrestricted to the details of any foregoing embodiments. The inventionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

The reader's attention is directed to all papers and documents which arefiled concurrently with or previous to this specification in connectionwith this application and which are open to public inspection with thisspecification, and the contents of all such papers and documents areincorporated herein by reference.

Reference herein to a “medical scoping device” is intended to refer toendoscopes, enteroscopes, sigmiodoscopes, gastroscopes, colonoscopes andpanendoscopes and is used interchangeably and is intended to include allscoping instruments whether passed directly or through a cannula into abody/organ/tissue cavity. Endoscopy involves the inspection of theinside of the body or body cavity and includes arthroscopy, cystoscopy,gastroscopy, uteroscopy and colonoscopy whereas enteroscopy is theexamination of the small intestine including the duodenum, jejunum, andileum. In all instances the scopes are elongate flexible probes and itis intended that the covers of the present invention may be used inconjunction with all of the aforementioned scopes.

Accordingly a “medical scoping procedure” is intended to include anymedical procedure or examination that involves use of a medical scopingdevice as hereinbefore described.

The distal end the cover is the end which is commensurate with thedistal end of the medical scoping device shaft which comprises lenses,channels such as air suction conduits and light guides. It is the endwhich is furthest from the endoscopist/colonoscopist and as such is theend of the instrument which is deepest within the patient's body andtherefore it is the end which will first come into contact with a loopedsegment of the bowel. Accordingly, a distal movement of the endoscope isa forward movement i.e. further into a patient's bowel. Conversely, theproximal end of the sheath is the end which is commensurate with theproximal end of the endoscope and which is the end situated nearest theoperator and therefore a proximal movement of the endoscope is abackward movement towards the operator.

In one aspect of the present invention provides the medical scopingdevice cover provides an improved means of conducting probingprocedures, avoiding the problems associated with looping and generallyimproving the speed and comfort of the procedure for the patient. Thecover is arranged for application over the medical scoping device shaftso as to surround it and to extend along at least a distal part or tipregion of the shaft. The cover comprises an inner surface at least apart of which grips the shaft of the medical device and holds the coverin place against movement longitudinally of the shaft duringdisplacement of the shaft through a body passage into which the shaft isinserted in use, and the outer surface of the sleeve is provided withprotrusions configured to cover the endoscope shaft onto which the coveris applied whereby the protrusions when fanned out or extended from theshaft body provide a means for gently holding on to or gripping theinner surface of the body passage and opening up the lumen. The grippingof the body passage by the projecting elements is enhanced by removal ofany air in the body passage so that the wall of the body passage intowhich the medical device has been inserted collapses on to theprojecting elements and is drawn into the spaces between the projectingelements thus the body passage walls are held against the cover and arearward or proximal movement of the device causes the body passage toconcertina behind the gripped portion of the body passage, the scope tostraighten and the lumen ahead of the distal end to straighten and openup.

Preferably, the at least a part of an inner surface of the cover that isin contact with the distal end of the medical scoping device shaft mayeither be upper and lower end regions of the cover or the entire innersurface.

Preferably, the elongate tubular member may comprise a contiguoustubular member or alternatively it may be provided with slits or gaps orridges running in a longitudinal direction commensurate with thelongitudinal axis of the medical scoping device. In this embodiment ofthe invention the number of slits is directly proportional to the numberof projecting elements, the projecting elements being positioned in theslits or gaps between the solid parts of the cover.

Preferably, the projecting elements are in the form of bristles, spikes,spines, fins, wedges, paddles or cones and are arranged to extendoutwardly and away from the outer surface of the elongate tubularmember. The projecting elements may be cylindrical, conical or taperedand the tips of the projecting elements may either be rounded orblunted.

Preferably, the projecting elements may be formed integrally with theouter surface of the elongate tubular member or alternatively they maybe attached or moulded thereto. In the instance that the cover isprovided with longitudinal slits or gaps then the projecting elementsmay be provided attached to or moulded in between adjacent slits orgaps.

In the instance of the projecting elements being attached or moulded tothe outer surface of the cover, the bases of the projecting elements maybe hinged onto the outer surface of the elongate tubular member. In thisway the projecting elements are hinged and capable of moving between aresting position, where the tips extend away from the scoping deviceshaft at a selected angle, to a position wherein the tips of theprojecting elements are substantially parallel to a longitudinal axis ofthe enteroscope/endoscope shaft and also to a position wherein theprojecting elements project outwards from the enteroscope/endoscopeshaft at an angle of less than or equal to perpendicular to thelongitudinal axis of the medical scoping device shaft. In this positionthe projecting elements can be said to be fanned out.

In the alternative embodiment, the projecting elements are attached attheir base to circumferentially positioned cross members situated belowthe level of the outer surface of the casing to form a hinge. In thisway the projecting elements are hinged and capable of moving between aresting position, where the tips extend away from the scoping deviceshaft at a selected angle, to a position wherein the tips of theprojecting elements are substantially parallel to a longitudinal axis ofthe enteroscope/endoscope shaft an fall below the level of the outersurface of the casing and also to a position wherein the projectingelements project outwards from the enteroscope/endoscope shaft at anangle of less than or equal to perpendicular to the longitudinal axis ofthe medical scoping device shaft. In this position the projectingelements can be said to be fanned out.

Preferably, the tips of the projecting elements when in a position ofbeing substantially parallel to the longitudinal axis of the medicalscoping device may either be directed towards a distal or proximal endof the covered medical scoping device. It will be appreciated that theprojecting elements can be said to be moveable between at least three,and in some embodiments, four positions. In a first position theprojecting elements project at a selected acute angle away from thelongitudinal axis of the medical scoping device, this is the “restingposition”. In a second position when the covered medical scoping deviceis pushed in a distal direction into a patient's lumen forces act uponthe projecting elements to push them towards the shaft of the scopingmedical device so that they are substantially parallel to thelongitudinal axis of the medical scoping device and so that the tipspoint towards a proximal end of the scope. In a third position, when thecovered scoping device is withdrawn in a proximal direction theprojecting elements are caused to fan out and are substantiallyperpendicular to the longitudinal axis of the shaft of the scopingmedical device. In some embodiments of the invention the projectingelements are moveable beyond the third position and flick over at acritical point so that the tips point towards the distal end of thescoping medical device, this is the fourth position, and is the positionin which the medical scoping device can be withdrawn through the orificeinto which it was initially inserted. Alternatively, the cover may beprovided with a projecting elements closure means optionally in the formof a sleeve which can be drawn from a distal to a proximal end and whichflattens the projecting elements from the third or resting position tothe second position described above.

Accordingly in some embodiments of the invention where the projectingelements do not flick over at a critical point the covers of the presentinvention are preferably provided with a projecting element closuremeans that moves the projecting elements from a fanned out position to aposition where they are substantially parallel to the longitudinal axisof the shaft of the medical scoping device. Preferably, the projectingelements closure means is in the form of a sleeve that is capable ofbeing drawn over the projecting elements. Preferably, the projectingelements closure means is provided with a draw string or the like whichallows the sleeve to unfurl in a proximal direction.

Preferably, the bases of the moulded projecting elements are raised sothat they form a bump or bulge on the outer surface of the elongatetubular member under which is an air pocket. The projecting elements arehinged or moveable about their bases to enable them to be moveable andin one embodiment to flick over beyond a critical point of maximumflexion so that the tips point distally to allow for a smooth removal ofthe medical device from the body passage and orifice into which thedevice has been inserted.

Preferably, the bases of the moulded elements are attached at their baseto circumferentially positioned cross members. The projecting elementsare hinged or moveable about their bases to flick over beyond a criticalpoint of maximum flexion so that the tips point distally to allow for asmooth removal of the medical device from the body passage and orificeinto which the device has been inserted.

Preferably, the hinges at the bases of the projecting elementsfacilitate movement of the projecting elements between a restingposition at an acute angle, preferably between 85 to 35° and morepreferably about 55 to 75° in addition to a tendency to collapse to thesecond position i.e. one that is substantially parallel to thehorizontal access. The hinges also facilitate a tendency to resistflexion to a point substantially perpendicular to the longitudinal axis(90°) and a tendency to flatten to an obtuse angle i.e. flipping over toabout 170-180° upon extubation after a critical angle is exceeded.

Preferably, the hinges maybe of variable stiffness.

Preferably, the bristles are between 2 to 20 mm in length from base totip and more preferably they are between 4 to 15 mm in length and morepreferably still are between 4 to 10 mm in length.

In embodiments of the invention where multiple rings of projectingelements are provided then preferably, the length of the bristles ismarginally shorter at either or both the distal and proximal ends of thecover. Thus the central region of the cover comprises bristles of alonger length so that the bristles of the cover when seen in side vieware elliptical.

Preferably, the projecting elements that are of a longer length are moreflexible and are constructed of a softer material than projectingelements of a shorter length and more preferably still the longerprojecting elements are everted.

Preferably, in the embodiments where the projecting elements are in theform of bristles or hairs the diameter of the projecting element isbetween 0.5 to 3.0 mm and more preferably still is about 1.5 mm.

Preferably, the projecting elements may be either straight or curved.Projecting elements with a slight curve offer the advantage of when theyabut or contact the colonic wall there is a tendency to deform, so thatthe tip of the projecting element bends out rather than pressing into orimpinging onto the colonic wall causing trauma. The slight curve revealsthe under surface of the projecting elements into the colonic wall,pushing it away and flattening folds as they pass by.

It will be appreciated that the elongate tubular member and theprojecting elements are constructed of a suitable biocompatible materialso that they are flexible and resiliently deformable, suitable materialsinclude but are not limited to a material selected from the groupcomprising polymers, plastics, elastomers and rubbers. Suitable examplesinclude polyurethane, polychlorpropene, natural rubber, silicon andsilicon elastomeric materials a particularly preferred material is athermoplastic elastomer for example and without limitation Pebax®.

Preferably, the elongate tubular member and projecting elements areconstructed from the same or differing materials, from a manufacturingperspective a cover comprising the same construction material ispreferred however it is within the scope of the invention to constructthe projecting elements from a different material to the elongatetubular member's main body.

Preferably, the projecting elements in a resting position are acutelyangled with respect to the central longitudinal axis of the cover andmore preferably the projecting elements are positioned at an angle ofbetween 35° to 85° with respect to a central longitudinal axis of acentral line of the cover, more preferably they are angled at about 55°to 75° from the cover's central longitudinal axis.

Preferably, the projecting elements are positioned in rings runningcircumferentially around the cover and along the length of the cover.Ideally, there is at least one or more rings and more ideally two ringsand in other embodiments up to 20 rings. It will be appreciated that theprojecting elements may, in some embodiments, be provided as a singlering.

Preferably, each ring comprises between 4 to 16 projecting elements andmore preferably between 5 to 10 projecting elements. The rings ofprojecting elements may be aligned uniformly in parallel descending thelength of the cover or they may be off set against one another.

Preferably, the rings of the projecting elements are spaced apart by adistance of between 2.5 cm to 0.5 cm and more preferably still by about1.5 cm to 0.5 cm.

It will be appreciated that the cover of the present invention may beconstructed uniformly, that is to say that the projecting elements mayall be of equal diameter, length, number in ring and evenly spaced apartrows of rings in a uniform manner. Alternatively, it is included withinthe scope of the invention that any one or more of these parameters maycomprise a mixture of different parameters, that is to say that thecover may comprise projecting elements of differing diameters, lengths,numbers in rings and the rows of rings may be differentially spacedapart in a non-uniform manner.

Preferably, the cover further comprises an over cuff. The over cuff isplaced over the cover of the present invention. In the embodiments ofthe invention where the cover comprises slits or gaps, the over cuff isalso provided with slits or gaps of the same dimensions as that of thecover so that the projecting elements are able to protrude through thealigned slits or gaps.

Preferably, the over cuff is of the same or approximately same length asthe cover.

Preferably, the over cuff is constructed of a polycarbonate or the like.

Preferably, the first ring of projecting elements, i.e. the most distalring, is positioned between 1 to 20 mm from the distal end of the coverand more preferably it is positioned between 5 to 15 mm from the distalend.

Preferably, in the instance of multiple rings the last ring ofprojecting elements, i.e. the most proximal ring, is positioned between1.0 cm and 10.0 cm from the proximal end of the cover and morepreferably it is positioned between 1.0 cm and 3.0 cm from the proximalend.

Preferably, the cover is provided with one or more apertures positionedat the proximal end of the cover. The apertures are provided so thatthey may slot over the securing means of an applicator casing therebyholding the cover in position for receiving an enteroscope or endoscopeinto the hollow body of the elongate tubular member. More preferably,the cover comprises at least four apertures evenly spaced apart forsecuring the cover to the applicator casing prior to insertion of thescope into the cover.

Preferably, the cover further comprises a viewing means mounted at itsdistal end. The viewing means is preferably a disposable transparenttubular open ended cap and may be in the form of a plastic or Perspex®cap attachment which can facilitate maintaining image focus and correctdepth of field. The addition of a transparent plastic open ended cap canadvantageously permit entry into the ileum.

Preferably, the outer surface of the cover (i.e. the surface of thecover that is, in use, in contact with the patient's body cavity) iscoated with a lubricating agent that maybe a hydrophobic or hydrophilicagent. Suitable hydrophilic agents include, but are not limited to,hydrogel polymers such as poly(2-hydroxyethyl methacrylate) (PHEMA) andComfortCoat®, suitable hydrophobic agents include, but are not limitedto, silicone, glycerine, olive oil, castor oil, chlorotrifluoroethylene(CTFE oil) and polyphenyl ethers or a mixture thereof.

Preferably, the lubricating agent is sprayed or brushed onto the outersurface of the cover and more preferably still, is coated only onto thedistal end of the cover so that only the outer surface of distal end ofthe cover is coated leaving the proximal surface and under surface ofprojecting elements free of the lubricating agent thereby providinggreater purchase on the surface of the body passage during extubationfacing aspects e

Preferably, the cover is detachable or removable from theendoscope/enteroscope. In use, the cover of the present invention isplaced about the medical device shortly before insertion into thepatient under investigation and is removed from the medical device oncethe examination/procedure has been completed. The cover of the presentinvention may then be disposed of.

Preferably, the cover of the present invention is provided with theprojecting elements along its length and especially when in position ona medical scoping device at its distal end. The main difficulty withperforming colonoscopy is the anatomy. Some lengths of bowel areattached to loose mesentery rendering them mobile and subject to loopingwhilst other parts are fixed, often causing a sharp change of directionwhich leads to greater friction when trying to advance around the bend.Furthermore, depending upon the tightness of the bend, the tip of thecolonoscope (or the flexed knuckle that has been induced at the end ofthe instrument to steer round the bend) abuts the side wall of the bendso that forward momentum induced by the endoscopist is directed in theopposite direction to the one desired preventing any advance and leadingto trauma at the point of contact and increased looping in the mobilesegment. Because there is an angle to be negotiated at these fixedpoints, forward vision may be lost as well.

Until the acute bend has been negotiated pushing the colonoscope forwardleads to the development of a loop in the mobile segment. This in turncreates tension on the mesentery causing pain, slowing the heart rateand lowering the blood pressure. Further attempts to “push round theloop” can lead to damage of the bowel both in the looped segment and atthe tip of the colonoscope if its end is hard against the wall of thebowel. Advantageously, the projecting elements of the cover of thepresent invention provide an ease of movement around the relevantregions thereby reducing tension between the bowel surface and theinstrument and allowing for the colon to be concertinaed behind thedistal end.

In the present invention the projecting elements are designed to openout when the scope is withdrawn from a patient and this creates a fan orspread of projecting elements that gently support the wall of the bodypassage and especially the colon. When the colon is tortuous,withdrawing the colonoscope draws the colon back, opening up the pathahead. Forward motion simply causes the hairs to collapse against theside of the sleeve so that they are in the so called second position andare substantially parallel to the longitudinal central axis of the scopeaccordingly the scope can be advanced without hindrance. In practice thetechnique of forward advancement and drawing back allows for rapidconcertinaing of the colon behind the cover and also advantageouslyopens the way ahead so reducing loss of vision in the procedureespecially when looping. Furthermore, it enables rapid advancementthrough a tortuous colon without losing position.

As regards the suctioning effect or “wrap around” which is an entirelynew concept in the field, suction of air draws the colonic wall intoclose apposition to the colonoscope wall, wrapping it around the coverand in between the projecting elements into the spaces therebetween.This in turn increases the backward friction and allows the colonoscopeto be withdrawn, shortening and telescoping the proximal colon over theshaft whilst not allowing the distal end or tip to slip backwards.

Yet further advantages of the cover of the present invention includeclose approximation of the colonic wall to the projecting elements orhairs enhancing tip grip, maintenance of distal tip position whenreducing a proximal loop, straightening out the distal bowel tortuosity.

It will be appreciated that the cover of the present invention may beused in conjunction with existing scopes and that no specialmodifications to scopes currently used in practise is required.

In one aspect of the invention the applicator comprises twocomplimentary casings that engage together to form a hollow shell, theengaging means may be in the form of snap-fit male-female elements,clips or locks or the like the specifics of which are not intended tolimit the scope of the invention.

Preferably, the securing means of the applicator comprise rod likeprojections that engage with apertures provided at the proximal end ofthe cover, the apertures in the cover are sized and shaped so as toaccommodate the rods therein. Thus, the apertures of the cover areplaced over the rods to secure the cover within the casing or shell andthen the medical device scope is inserted into the hollow space of theelongate tubular member. Preferably, the number of securing means (rodsand apertures) are commensurate on the applicator and cover.

Preferably, the applicator may further include an end cap that isslotted into position and held secure so that when the medical scopingdevice is inserted into the application its distal end abuts and engageswith the end cap.

Also included within the scope of the invention is a kit of partscomprising at least one cover having all the features as herein beforedescribed, a medical scoping device that includes an air suction means,an applicator for placing the cover about the scope and optionally atransparent open-ended cap held either within the applicator or attachedto the cover itself.

It will be appreciated that the cover of the present invention can beconstructed with various diameters so that it may be used to fit overthe shaft of existing medical scoping devices. For example, paediatricscoping devices comprise shaft diameters of around 11 mm whereas anadult scoping device shaft diameter is in the region of 12 mm, the coverof the present invention may be constructed with suitable diametersaccording to a user's requirements.

The invention will now be described with reference to the Figures.

FIG. 1 shows a cover (1) according to the present invention, the covercomprises a number of projecting elements (2) in the form of bristles,moulded at an acute angle with respect to the longitudinal axis of thecover to the outer surface (3) of the elongate tubular member. FIG. 1shows the projecting elements in their resting position and the tipspointing towards the proximal end (6). The projecting elements (2) aremoulded at their base to form a raised portion or bump (4). A small airpocket is formed beneath the raised portion or bump (4) on the innersurface (7) of the cover which allows for flexibility of the projectingelements about their base in use and especially when negotiating theconfines of a body passage. As described herein before the projectingelements are angled, at rest in the so called first position, to around45° to 65° towards the proximal end (6) of the cover and with respect toa central longitudinal axis of the cover and, in a forward or distalmovement within a body passage once the endoscope or enteroscope hasbeen inserted into the hollow (8) of the cover, the projecting elementsare flattened so as to be approximately parallel to the saidlongitudinal axis with the projecting elements tips pointing towards theproximal end (6). This is the second position. The projecting elementsare fanned out or expanded into a third position when the covered scopeis withdrawn in a proximal movement. During this reverse movement theendoscopist can apply the air suction means to withdraw air from thebody passage causing the body passage wall to partially collapse aboutthe projecting elements (2) and be drawn into the spaces (3) between theindividual projecting elements and the spaces between rings and rows ofrings of projecting elements. In this way the wall of the body passageis gripped and wrapped around the cover, if further forward or distalmovement is applied the body passage wall remains gripped by theprojecting elements and effectively bunches up or concertinas in theproximal area thereby allowing the distal end to move forward andovercome the looping or bend obstacle. In some embodiments of theinvention the projecting elements (2) are capable of flicking orflipping over past the critical point of maximum inflexion at 90° sothat the tips point towards the distal end (5) in a so called fourthposition, making withdrawal of the device through the relevant orificemore comfortable for the patient. Alternatively they may be flattenedagainst the cover main body as depicted in FIG. 9B as described hereinafter. In use, in preliminary trials endoscopists have reported that thecover of the invention remains in position on the flexible medicalscoping device shaft and that the projecting elements do not impede theperiphery of the visual field.

The projecting elements may be in form of bristles (FIG. 8A), fins orpaddles (FIG. 8B), cones (FIG. 8C), bulbs, stalks or buds (FIG. 8D) orany other flexible projection (FIG. 8E).

The projecting elements are provided in rings, typically of about 1 to10 rings and more typically of two rings in uniform circumferentialformation and evenly spaced apart with projecting elements being of amarginally shorter length in the first (distal end (5)) and last(proximal end (6)) rows. At the proximal end (6) the cover is providedwith several apertures (16) which are capable of fitting over rodsprovided on the applicator. FIG. 2 shows a transverse section throughthe cover that has bristle type projecting elements.

With regard to FIG. 3, the distal end (5) of the cover is seen ingreater detail. The distal end comprises a head (14) and a profiled endregion (9, 10) over which a transparent cap (13) may be placed and heldin position by clips (11, 12) or the like. This distal region is the endthat is furthest in the patient and provides the light and lens throughwhich the endoscopist can observe the body passage. In some embodimentsof the invention the cap (13) is provided with the cover or may beplaced in the applicator and the scope is inserted through the cover andcaused to engage with the cap in situ. The end cap is an optionaladditional feature which can be provided if desired with either thecover or the applicator.

In order to place the cover about an enteroscope or endoscope the coveris held in place within an applicator comprising a pair of casings (17,18). FIG. 4 shows a disassembled applicator and the securing means (19)of the casings (17, 18) in the form of rods which are inserted intoapertures (16) of the proximal end of the cover. Although not shown inFIG. 4 an end cap can be held in place at the distal end. In FIG. 5, thecasings are fitted together by any suitable means and the cover held inposition within the shell or casing. In order to fit the cover about ascope, the scope is inserted into the hollow (8) and pushed up into thecasing towards the distal end (5) whilst the cover is secured about itsproximal end (5) by means (16, 19). FIG. 6A shows a top view of anassembled casing and FIG. 6B shows a side view with the cover in placeinside, FIG. 6C shows a top view of a disassembled applicator and cover,FIG. 6D shows a proximal end view with the apertures of the cover overthe rods stretching the cover to form an interior space 20 through whichthe scope is inserted and FIG. 6E shows a distal end view with theviewing hole which may also include the end cap. In one aspect of theinvention there is provided a kit of parts which may optionally includea viewing means attachment (20) optionally provided with a portal (21)for removing under suction any excess fluid (FIG. 7).

As mentioned herein before, in some embodiments of the invention theprojecting elements are not configured to adopt the fourth positionwhere the tip ends are pointed in a distal direction following a flipover past the critical point at maximum inflexion. In such embodiments,the cover is provided with a projecting element closure means (23)typically in the form of a sleeve (FIGS. 9A and 9B). To close theprojecting elements, in order that the scoping medical device can becomfortably withdrawn out of the orifice into which it was inserted, theprojecting elements closure means is pulled over the projecting elementsby a cord or line or string (24) so that sleeve (23) unfurls in aproximal direction over the projecting elements (2) thereby flatteningthem against the scope shaft (E). Once flattened (FIG. 9B) the scope canbe withdrawn from the patient.

In an alternative embodiment of the invention the cover is provided withslits or gaps (28) running in a longitudinal direction and between thedistal (A) and proximal (B) regions of the cover, in this embodiment thecover is also provided with an over cuff (25). The over cuff itself isalso provided with slits or gaps (30) between its proximal and distalends that are of approximately commensurate dimensions as the slits orgaps in the cover so that, when the over cuff is placed over the cover,the slits or gaps in both the cover and over cuff are aligned, providingcontinuous spaces (29) through both items whilst at each of the distal(A) and proximal (B) ends the cover and over-cuff have continuous rings(31 and 32). The slits or gaps through which projecting elements canprotrude are spaces (29) defined by adjacent strips of the cover (28)and over cuff (30) between the proximal and distal ends. FIG. 10A showsa plan view of a cover and over cuff (25). The over cuff has a snug fitover the cover and is typically constructed of a polycarbonate or otherplastics material, projecting elements (2) protrude outwardly betweenstrips (26) of the over cuff and at the distal tip the over cuff itmarginally overlaps the cover providing a rim (27) around hollow (8). Atthe proximal end of the cover and over cuff (FIG. 10B), the differentiallengths of projecting elements can be seen, the longer elements (2A) atthe distal end project beyond the shorter elements (2B) at the proximalend by between 2-4 mm. Each projecting element protrudes between theslits or gaps (29) defined by the strips (26 and 28) of the over cuffand cover respectively. FIGS. 11A through to 11D show various views ofthe cover and over-cuff of the present invention and FIG. 11E shows thecover and over cuff arrangement when placed over the distal end shaft(33) of a medical scoping device.

In use, as depicted in the series of FIGS. 12A to 12D, the medicalscoping device distal tip with the cover and over cuff (3, 25) isinserted via the anus (34) into the colon of an individual underinvestigation. On inserting the medical scoping device, cover and overcuff into the patient the projecting elements are moved from an at restposition, referred herein before as the first position to a secondposition where they are flattened towards the medical scoping deviceshaft the so called second position (FIG. 12A). The distal end tip ofthe medical scoping comprises a channel (37) through which a lightsource, image relaying mean and air suction is supplied. Duringintubation, the projecting elements are designed to collapse into thedevice during insertion through the anus. This exposes the smooth lowfriction surface of the cover and over cuff to the mucosa to aidintubation.

Negotiating the sigmoid loop is improved by at least one or two rows ofprojecting elements that offer different functions depending on therequirement of the endoscopist. The longer distal hairs are soft andslightly everted so that they gently grip the mucosa to maintain tipposition when the endoscope is straightened “soft grip”. When complexloops form and there is a need for stronger grip at the tip to enabletheir reduction, conventional suction draws the colon close to thesurface of the cover creating “wrap around”. The colonic mucosaenvelopes the proximal shorter projecting elements providing a tighthold while the colonoscope is shortened to enable the bowel toconcertina over the shaft of the endoscope without tip slide-back. “Wraparound” avoids the use of acute tip deflection to maintain tip positionand reduces the need to torque. Endoscopists report that both techniquesare intuitive and simple to perform. Straightening a looped endoscopewithout losing tip position or vision advantageously potentially reducestime to caecum and patient discomfort. In the course of preliminarytrials with the device of the present invention, endoscopists havereported no impediment to intubation and a greater amount of exposure ofmucosa in the sigmoid area during withdrawal.

The flexible shaft (33) of the medical scoping device is advanced in adistal direction through the colon towards the bend or loop region (36)of the of the colon (FIG. 12B) whilst insufflating the colon immediatelyforwards of the distal tip. The projecting elements once passed the anusrevert to their resting first position. As the scope passes further upthe colon and encounters the loop region the projecting elements engagewith the colon wall in a soft grip (third position where the projectingelements fan out and the endoscopist can perform a controlled proximalwithdrawal flattening the colonic folds for good visualisation (FIG.12C). As regards improved visualisation, the distal row of longerprojecting elements is designed to open the colonic lumen for closeinspection. Viewing the proximal surface of the colonic folds isdifficult and time consuming. The projecting elements of the cover ofthe present invention act to gently open and flatten the colonic foldsfor inspection during withdrawal, endoscopists report that the cover ofthe present invention provides distinct improvements. Improvedvisualisation is important for identifying small pre-malignant andmalignant lesions that might be tucked out of sight when performingconventional endoscopy. Visualisation is further enhanced when using thecover of the present invention, especially with wide vision endoscopes.

As mentioned herein before two of the significant disadvantagesassociated with colonoscopy and scoping procedures is firstly that thenatural folds of the colon wall hamper the colonoscopist's ability tovisualise the entire surface of the mucosa and secondly in maintainingand controlling position of the distal tip during the procedure. Thesetwo difficulties are resolved as follows:

For improved visualisation, the projecting elements gently open thelumen and evert thereby flattening the colonic folds for inspectionduring withdrawal. Visualisation is further enhanced as the colonicfolds slowly revert to their normal anatomical position permitting lightto play across the mucosa, thus enabling careful visualisation of thesurface of the mucosa that was hitherto hidden or difficult to view.

As regards, tip position control, the projecting elements of the devicegently stabilise the tip of the scoping device within the lumen of thecolon or small intestine immediately prior to and during therapeuticprocedures. This has the advantage of permitting the endoscopist thereassurance that the tip will remain in position from the stage ofvisualising a lesion or polyp until completion of the therapeuticprocedure.

In use, the distal row of the projecting elements are designed to flareoutwards on withdrawal. They keep the instrument tip in the central partof the bowel lumen as the instrument moves backwards, gently holding themucosa to prevent the tip from flipping backwards, they maintainposition during therapy and improve all-round visualisation. Duringextubation they evert the folds enabling their proximal surface to beviewed.

In order to negotiate the loop or bend the endoscopist can apply airsuction so that the colon wall (38) collapses onto the shaft (3) andinto the spaces between adjacent rings of projecting elements (39), theprojecting elements still being in the third position (FIG. 12D). Thecolon wall concertinas about the shaft (3) and the endoscopist can thencease suction so that the colon wall straightens and the scope can befurther advanced.

On withdrawing the scope especially through the anus the projectingelements can flip over to the fourth position so that the scope can becomfortably withdrawn. During controlled tip withdrawal, the cover ofthe present invention is designed to provide controlled extubation.During conventional withdrawal there is a tendency for the colonoscopetip suddenly to slip backwards. This happens especially when passing abend or flexure and the “missed” area then has to be re-intubated,sometimes with the creation of a painful loop. The long, soft, distalprojecting elements of the present invention prevent sudden tip slippageand hold the tip in the centre of the colonic lumen providing bothcontrol and good visualisation as the endoscope is withdrawn.

The invention claimed is:
 1. A method of endoscopic visualization of abowel and/or small intestine, the method comprising: inserting a medicalscoping device shaft having an air suction conduit for removing air froma body passage into the bowel or small intestine of a patient underinvestigation, the medical scoping device further comprising a coverreleasably attached to the medical scoping device shaft and covering atleast a part of the shaft at its distal end, wherein the cover includesa member having an inner surface for gripping the shaft and an outersurface from which a plurality of projecting elements project radiallyoutwardly; advancing the medical scoping device in the direction of itsdistal end within the patient's bowel or small intestine, wherein theprojecting elements deflect to a first radially inward position tofacilitate advancing the medical scoping device; partially withdrawingthe medical scoping device toward its proximal end, such withdrawalcausing the projecting elements to deflect to a second radially outwardposition in which at least some tips of the projecting elements extenddistally further than a distal end of the cover and the distal end ofthe medical scoping device in response to contact with a lumen wall todilate a lumen of the bowel or small intestine while holding the medicalscoping device in position for visualization of the lumen and to evertand engage colonic folds that are more distal than the distal end of thecover and the medical scoping device whereby visualization is allowed asthe colonic folds revert to their normal anatomical position permittinga light from the medical scoping device to emit across a mucosa of thebowel or small intestine providing visualization of at least a portionof a surface of the mucosa; and withdrawing the medical scoping devicewherein the projecting elements deflect so that the tips of theprojecting elements extend distally further than the distal end of thecover and the distal end of the medical scoping device to facilitatewithdrawal of the medical scoping device.
 2. The method of claim 1,wherein the projecting elements are substantially perpendicular to thelongitudinal axis of the shaft of the medical scoping device in thesecond position.
 3. The method of claim 1, wherein, in response to whenthe projecting elements dilate the lumen and evert, at least some of theprojecting elements can flatten colonic folds in the bowel or smallintestine for inspection in the second position.
 4. The method of claim1, wherein the projecting elements comprise bristles, spikes, spines,fins, wedges, paddles or cones that are arranged to extend radiallyoutwardly from the outer surface of the medical scoping device shaft. 5.The method of claim 1, wherein the projecting elements comprise abiocompatible flexible material selected from the group consisting of apolymer, plastic, elastomer, silicon, a silicon elastomeric material anda rubber, and combinations thereof.
 6. The method of claim 1, whereinthe cover further comprises a viewing device at the distal end.
 7. Themethod of claim 1, wherein the projecting elements deflect at a criticalpoint of maximum flexion so that at least some of the tips of theprojecting elements point towards and extend beyond the distal end ofthe medical scoping device during the partially withdrawing and/orwithdrawing steps.
 8. A method of endoscopic visualization of a boweland/or small intestine, the method comprising: inserting a medicalscoping device shaft having air suction for removing air from a bodypassage into the bowel or small intestine of a patient underinvestigation, the medical scoping device further comprising a coverreleasably attached to the medical scoping device shaft and covering atleast a part of the shaft at its distal end, wherein the cover grips theshaft and comprises a plurality of projecting elements that projectradially outwardly; advancing the medical scoping device in thedirection of its distal end within a lumen of the patient's bowel orsmall intestine or bowel and small intestine, wherein the projectingelements deflect to a first radially inward position to facilitateadvancing the medical scoping device; partially withdrawing the medicalscoping device toward its proximal end, such withdrawal causing theprojecting elements to deflect to a second radially outward position atwhich at least some tips of the projecting elements extend distallyfurther than a distal end of the cover and the distal end of the medicalscoping device in response to contact with a lumen wall to dilate thelumen while holding the medical scoping device in position forvisualization of the lumen and to evert and engage colonic folds thatare more distal than the distal end of the cover and the medical scopingdevice whereby visualization is allowed as the colonic folds revert totheir normal anatomical position permitting a light from the medicalscoping device to emit across a mucosa of the lumen providingvisualization of at least a portion of a surface of the mucosa; andwithdrawing the medical scoping device wherein the projecting elementsdeflect so that at least some of the tips of the projecting elementsextend distally further than the distal end of the cover and the distalend of the medical scoping device to facilitate withdrawal of themedical scoping device.
 9. The method of claim 8, wherein, in responseto when the projecting elements dilate the lumen and evert, at leastsome of the projecting elements that extend beyond the distal end of thecover and the medical scoping device flatten colonic folds in the bowelor small intestine for inspection in the second position.